OPKO Health and Pfizer’s Ngenla, a treatment for childhood growth hormone deficiency, has received approval by the US Food and Drug Administration (FDA). The treatment for the rare disease, which causes short stature and delayed puberty, had been rejected once by the agency with a request for more […]
Looking Past Amyloid – The Future of Alzheimer’s Therapeutics
One of the key therapeutic targets in Alzheimer's disease is amyloid, a sticky protein that builds up in clumps outside neurons, causing cell death and cognitive decline. However, new therapeutics targeting the protein have only shown mild efficacy in delaying disease progression. As a result, drug […]
7 Key Drug Shortages to Watch
Drug shortages have rocked the US, imperiling access to therapeutics for millions of patients with a wide array of diseases and conditions. A new Becker’s Hospital Review article lays out 7 of the most prominent drug shortages to watch. One is the attention deficit hyperactivity disorder (ADHD) drug […]
Pharma’s Legal Challenges Against US Drug Pricing Negotiations Face an Uphill Battle
Merck, BMS, and three industry groups filing lawsuits against the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) may face an uphill battle in stopping upcoming Medicare drug pricing negotiations. The suits filed by the first two are based on […]
NICE Requests More Data Before Covering Mounjaro
The UK’s National Institute for Health and Care Excellence (NICE) has sent a request to Eli Lilly asking for more data regarding Mounjaro (tirzepatide) before it will cover it for NHS patients. The decision comes based on data comparing the drug’s efficacy to Novo Nordisk’s rival drug Ozempic and […]
FDA Approves Pfizer’s Treatment for Alopecia Areata in Adolescents
The US Food and Drug Administration (FDA) has approved Pfizer’s Litfulo (ritlecitinib) for use in adolescents with severe alopecia areata, an autoimmune condition that causes hair loss. The approval marks the first treatment for the psychologically damaging condition in teens. Positive results from […]
CDC Adcomm Hesitantly Recommends RSV Vaccines for Older Adults
GSK’s Arexy and Pfizer’s Abrysvo vaccines for respiratory syncytial virus (RSV) have received recommendations from the US Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP). While the committee voted almost unanimously in support of the vaccines […]
PhRMA Enters the Legal Fight against US Medicare Drug Pricing Negotiations
The pharmaceutical trade group PhRMA has entered the fray, joining BMS and Merck in filing legal challenges against the upcoming US Medicare drug pricing negotiations. Unlike the arguments raised by the two pharma giants’ complaints, which centered on the First Amendment, PhRMA’s argument hinges on […]
Pharma is Eyeing Supreme Court Case on Upcoming Medicare Drug Pricing Negotiations
With lawsuits recently filed by the pharma giants Merck and BMS, pharma seems set on bringing litigation over upcoming Medicare drug pricing negotiations to the US Supreme Court. Some analysts think that the companies are eyeing the highest court in the land due to some justices’ relationships with […]
Congress Asks Stakeholders for their Thoughts on the 340B Program
US senators from both sides of the aisle have issued a letter calling for input on the 340B Drug Pricing Program from stakeholders. The program provides eligible care centers with reduced prices on certain prescription drugs. Some stakeholders have complained about a lack of clarity and transparency […]
